Hospira™ Cefazolin Sodium Powder for Injection

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Cefazolin sodium 1.048 g equivalent to cefazolin 1 g

Διαθέσιμο από:

Pfizer New Zealand Limited

INN (Διεθνής Όνομα):

Cefazolin sodium 1.048 g (equivalent to cefazolin 1 g)

Δοσολογία:

1 g

Φαρμακοτεχνική μορφή:

Powder for injection

Σύνθεση:

Active: Cefazolin sodium 1.048 g equivalent to cefazolin 1 g

Μονάδες σε πακέτο:

Vial, glass, single dose, Type I vials with bromobutyl stopper, 1g per vial, 5 dose units

Kατηγορία:

Prescription

Τρόπος διάθεσης:

Prescription

Κατασκευάζεται από:

Orchid Chemicals and Pharmaceuticals Limited

Θεραπευτικές ενδείξεις:

Respiratory Tract Infection due to S. pneumoniae, Klebsiella species, H. influenzae, Staph. aureus (penicillin-sensitive and penicillin-resistant), and Group A beta-haemolytic streptococci. Injectable benzathine penicillin is considered to be the drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cephazolin in the subsequent prevention of rheumatic fever are not available at present. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefazolin.

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Vial, glass, single dose, Type I vials with bromobutyl stopper, 1g per vial - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light and moisture 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Ημερομηνία της άδειας:

2012-08-22

Αρχείο Π.Χ.Π.

Data sheet – New Zealand_ _
Version 2.0
Page 1
HOSPIRA™
CEFAZOLIN SODIUM POWDER FOR INJECTION
NAME OF THE MEDICINE
Cefazolin sodium
Chemical Name: Sodium (6
_R, _
7
_R_
)-3-[[(5-methyl-1, 3, 4-thiadiazol-2-yl)sulphanyl]methyl]-8-oxo-7-
[(1
_H_
-tetrazol-1-ylacetyl) amino]-5-thia-1-azabicyclo[4.2.0]
oct-2-ene-2-carboxylate
Molecular formula: C
14
H
13
N
8
NaO
4
S
3
Molecular weight: 476.5
CAS: 27164-46-1
DESCRIPTION
Cefazolin sodium is a white to off white crystalline powder with a
solubility in water of greater than
or equal to 100 mg/mL. Hospira™ Cefazolin Sodium Powder for
Injection contains cefazolin sodium
as a single ingredient.
Hospira™ Cefazolin Sodium Powder for Injection is a powder for
parenteral administration following
reconstitution. Each vial contains 1.05
_ _
g of cefazolin sodium which is approximately equivalent to 1
_ _
g of cefazolin. Each gram of cefazolin sodium contains 48.3
_ _
mg of sodium.
PHARMACOLOGY
MICROBIOLOGY
_In vitro_
tests demonstrate that the bactericidal action of cephalosporins
results from inhibition of cell
wall synthesis. Cefazolin sodium is active against the following
organisms
_in vitro_
:
_Staphylococcus aureus_
(penicillin-sensitive and penicillin-resistant).
Group A beta-haemolytic streptococci and other strains of streptococci
(many strains of enterococci
are resistant).
_Streptococcus pneumoniae _
_ _
_Klebsiella species_
_Escherichia coli _
_ _
_ _
_Enterobacter aerogenes_
_Proteus mirabilis _
_ _
_ _
_Haemophilus influenzae_
Data sheet – New Zealand_ _
Version 2.0
Page 2
Most strains of
_Enterobacter cloacae_
and indole-positive
_Proteus (Pr. vulgaris, Pr. morganii, Pr. _
_rettgeri)_
are resistant. Methicillin-resistant Staphylococci,
_Serratia, Pseudomonas, Acinetobacter _
_calcoaceticus _
(formerly
_Mima_
and
_Herellea_
species) are almost uniformly resistant to cefazolin.
_Disc Susceptibility tests _
Quantitative methods that require measurements of zone diameters give
the most precise estimates of
antibiotic susceptibility. One such procedure has bee